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3D Ultra Sound for Resection of Brain Tumors (Sono RCT)

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ClinicalTrials.gov Identifier: NCT02150564
Recruitment Status : Unknown
Verified October 2016 by Dr Aliasgar V Moiyadi, Tata Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2014
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Aliasgar V Moiyadi, Tata Memorial Hospital

Brief Summary:
Phase 3 randomized open labeled trials will evaluate the 3 D navigable ultrasound (SonoWand) in improving the extent of resection in intra-axial brain tumors. All patients will undergo resective surgery. In the experimental arm, a navigable 3 D ultrasound will be used. In the standard arm, only navigation will be used. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue (histopathological correlation).

Condition or disease Intervention/treatment Phase
Patients With Resectable Brain Tumors Device: Sonowand Procedure: Navigation Phase 3

Detailed Description:

Routine presurgical evaluation of all patients will be conducted. The preoperative use of steroids, antiepileptics and other medications would be as per standard procedure and would be documented. In addition detailed MRI evaluation will be performed (including contrast enhanced MRI study, diffusion MRI, perfusion MR, MR spectroscopy, dynamic-contrast-enhanced MRI for permeability studies, as well as functional MRI, and tractography if required) not more than 1 week prior to the date of surgery.

Navigation specific MR sequences would be performed in all patients (both arms).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of 3-D Navigable Ultrasound in Resection of Intra-axial Brain Tumors - A Randomized Controlled Study
Study Start Date : March 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Navigation only group
Sonowand system will be used for navigation control arm as well as sononavigation experimental arm.Navigation will be used to plan the craniotomy and throughout the procedure as desired by the operating surgeon. At no point of time however will the Ultrasound be used.
Procedure: Navigation
Routine microneurosurgical procedures would be adopted in all cases.Sonowand system will be used for navigation control arm as well as sononavigation experimental arm. Image registration (on the previously imported DICOM images) will be done on the system and after positioning, patient-toimage registration will be completed. The Registration accuracy will be documented.

Experimental: SonoRCT Test group
Surgery to resect the tumor with the aid of sononavigation. In addition to the navigation function, the Ultrasound will be available at all times. This study will help in assessing the usefulness sononavigation in improving radicality of resection in malignant gliomas and also to access the accuracy of SonoWand in predicting residue.
Device: Sonowand
Initially a 2D acquisition will be performed and ultrasound parameters adjusted to obtain the best image resolution. Then anatomical landmarks will be identified if possible and the lesioncharacterized. Once the lesion is identified a rapid 3D-US acquisition will be performed. Tumor resection will proceed guided by the 3D US images using a trackable pointer to navigate. Repeat 3D US images will be obtained as many times as required during the surgery to update the information as tumor debulking proceeds. A final US will be obtained at the end of the procedure and after dural closure




Primary Outcome Measures :
  1. Percentage of patients where Gross total resection (GTR) achieved [ Time Frame: Post operative within 72 hrs. ]
    Measure: Volumetric MRI - residual tumor (in cc)


Secondary Outcome Measures :
  1. Accuracy of US [ Time Frame: Post operative within 72 hrours ]
    Measure: Sensitivity, Specificity, PPV, NPV


Other Outcome Measures:
  1. Further resection prompted [ Time Frame: Intraoperative ]
  2. Whether use of Sonowand prompted a further resection after the surgeon thought it was complete (unanticipated residue) [ Time Frame: Intra operative ]
  3. Survival (overall and progression-free) [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All radiologically-suspected, previously untreated, supratentorial malignant gliomas being considered for debulking surgery.
  2. Adults (above 18 years)
  3. Eligible for surgical therapy (craniotomy not stereotactic biopsy )
  4. Resectability : A lesion would be considered "resectable" if the surgeons feel that all the radiologically imaged lesion can be removed (with reasonable certainty). Only deemed resectable lesions will be included

Exclusion Criteria:

  1. Unfit for GA
  2. Unwilling for the study
  3. Unresectable lesion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150564


Contacts
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Contact: Dr Aliasgar V Moiyadi, M Ch Neurosurgery 022-27405076 ext 5076 aliasgar.moiyadi@gmail.com

Locations
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India
Advanced Centre for Treatment Research and Education in Cancer Recruiting
Mumbai, Maharashtra, India, 410210
Contact: Aliasgar V Moiyadi, M Ch (Neurosurgery)    91-22-27405076 ext 5076    aliasgar.moiyadi@gmail.com   
Principal Investigator: Aliasgar V Moiyadi, M Ch, DNB (Neurosurgery)         
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: Aliasgar V Moiyadi, M Ch Neurosurgery Prof and Neurosurgeon

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Responsible Party: Dr Aliasgar V Moiyadi, Prof and Neurosurgeon, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT02150564     History of Changes
Other Study ID Numbers: TMC-ACTREC 101
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Dr Aliasgar V Moiyadi, Tata Memorial Hospital:
Malignant gliomas
Sono RCT

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases